Clinical Trials In Human Medicines as per EU
Clinical Trials In Human Medicines as per EU: For its opinions on the approval of medicines, the European Medicines Agency (EMA) relies on the results …
Guidelines
The guidelines section keeps you up to date with respect to the current published guidelines of the pharmaceutical industry.
What is Clinical trial process flow as per FDA?
Before starting the clinical trial process flow, we will understand, What is a definition of a clinical trial? what is a clinical trial is in …
What is ICH Q10 in the Pharmaceutical Quality System?
In this article, we are going to learn about Scope of ICH Q10 and Objective of ICH Q10 in pharmaceutical. ICH Q10 In Pharmaceutical Quality …
50 Electronic Codes of Federal Regulation (e-CFR) in pharma
As per FDA there are 50 title of Electronic Codes Of Federal Regulation (E-CFR) In Pharmaceutical. In this article we will see the all 50 …
Important Difference between 21 CFR part 11 and EU Annex 11
21 CFR part 11 and EU annex 11 both are guidance for the electronic records and electronic signature. The guidances are applied to the computerized …
Understand 14 ICH guidelines in the pharmaceutical in an easy way
ICH full form: International Council on Harmonisation of a technical requirement for registration of pharmaceutical for human use. ICH is a joint initiative of three different regulatory bodies …